Assessment of Prepulse Inhibition for Shock Pain Reduction

This study has been completed.

Sponsors and Collaborators:	University Health Network, Toronto Dr. Douglas Cameron St. Jude Medical
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00193986

Purpose

Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's) is highly variable. It can be influenced by psychological factors, physical condition and the number of shocks delivered.

It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock.

A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a shock of equal energy without a prepulse.

Condition	Intervention
Pain Awareness From ICD Shocks	Device: Arbitrary Waveform Defibrillator

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock

Estimated Enrollment:	10
Study Start Date:	May 2005
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18+ Approved indication for implantation of an ICD Able and willing to provide informed consent Independently complete and understand the Mini Mental State Evaluation

Exclusion Criteria:

Pregnancy Cannot understand English or French Contraindicated for defibrillation testing because of risk of thromboembolism Deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded.

Having a Class I bradycardia pacing indication, requiring ongoing pacing support.

Visual problems which preclude reading the computer screen for the VAS test Severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position Do not achieve a score >24/30 on a Mini Mental State Exam

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193986

Locations

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Dr. Douglas Cameron

St. Jude Medical

Investigators

Principal Investigator:

Douglas A Cameron, MD

UHN

More Information

Study ID Numbers:	04-0252-B
Study First Received:	September 8, 2005
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00193986
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Prepulse
Defibrillator

Study placed in the following topic categories:

Shock
Pain

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009